Delivery device and related methods

ABSTRACT

A delivery device that includes a cutter for opening a barrier layer to provide fluid access to a dose chamber, and a diverting structure for direct air flow toward the dose chamber.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/688,852, filed Jan. 15, 2010, which claims the benefit of U.S.Provisional Patent Application Ser. Nos. 61/145,008, filed Jan. 15, 2009and 61/285,161, filed Dec. 9, 2009. Each of these applications isincorporated herein by reference in its entirety.

RELATED ART

Medicament in the form of dry powder may be delivered directly into thelungs, such as by inhalation. The powder may be prepared as an incipientformulation, a neat formulation, a blended formulation, or anycombinations thereof. Administering medicament in this manner may proveless invasive than other drug delivery techniques, such as hypodermicinjections. Direct inhalation of medicament may also allow smaller dosesto be used to achieve results similar to those of the same drug takenorally. Inhalation may also help avoid undesirable side effectsassociated with administering drugs orally or by injection.

SUMMARY

Aspects of the invention relate to devices, systems, and methods thatare used to deliver a dose of a drug/medicament (such as a liquid and/ora powder). The devices, systems and methods may include features thatallow the drug to be protected (e.g., from contamination and/ordegradation) prior to use, and to be delivered in a metered manner. Forexample, in some embodiments, the drug is isolated to a selectedvolume/dose chamber with a barrier, such as a foil layer that preventsthe ingress of contaminants and the egress of a dose from dose chamberprior to use. As a result, the initial location of the drug dose isknown, and the dose may be delivered predictably from the same startingpoint.

According to one aspect, a delivery device includes a primary airpathway having an upstream portion and a downstream portion. A dosechamber has an opening that, when opened, places the dose chamber andthe primary pathway in fluid communication at a position between theupstream portion and the downstream portion. A cover, when in a firstposition over the opening, closes fluid communication between the dosechamber and the primary air pathway. The cover moves to a secondposition to selectively open fluid communication between the dosechamber and the primary air pathway through the opening, and ispositioned to divert air to the dose chamber from the upstream portionof the air pathway when in the second position.

According to another aspect, a delivery device includes a primary airpathway and a dose chamber having an opening and a curved interiorsurface. A first portion of the curved interior surface is positioned toreceive air from the air pathway and a second portion of the curvedinterior surface is positioned to direct air toward the air pathway fromthe dose chamber. A moisture barrier covers the opening. A cutter movesfrom a first position to a second position to break the moisture barrierto open fluid communication between the dose chamber and the primary airpathway. The cutter is positioned to direct air to the dose chamber fromthe air pathway and to prevent a portion of air directed toward the airpathway by the second portion of the curved interior surface fromreaching the air pathway, when in the second position.

According to yet another aspect, a delivery device includes a primaryair pathway and a dose chamber having an opening. A moisture barriercovers the opening. A cutter that is on the dose chamber side of thebarrier moves, when actuated, to break the moisture barrier toselectively open fluid communication between the dose chamber and theprimary air pathway through the opening. The cutter is positioned todivert air to the dose chamber from the air pathway when in the secondposition.

According to yet another aspect, a delivery device includes a primaryair pathway having an upstream portion and a downstream portion. A dosechamber has an opening that, when opened, places the dose chamber andthe primary pathway in fluid communication at a position between theupstream portion and the downstream portion. A moisture barrier coversthe opening. A cutter moves, when actuated, to break the moisturebarrier selectively opening fluid communication between the dose chamberand the primary air pathway. The cutter protrudes at least partiallyinto the primary air pathway to divert air to the dose chamber from theupstream portion of the air pathway when moved to the second position.

In certain aspects of the invention, a dose of drug may be dispersed,fluidized, and/or metered from its initial location in the deliverydevice. The drug may be delivered as fine particles, mitigating, forexample, the occurrence of large clump(s), which may reduce therapeuticeffectiveness of the drug. A satisfactory combination of dispersion,fluidization and metering may also enhance drug delivery, for example,by allowing substantially all of the drug dose to be delivered, whichmay increase safety and lower cost and waste.

The following terms are used throughout this application and have thefollowing definitions.

The term “active” refers to the use of one or more external mechanismsand/or forces in addition to the patient's respiration.

The term “passive” refers to the use of the patient's respiration.

Other aspects, features and advantages will be apparent from thedescription of the following embodiments and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. In the drawings:

FIG. 1 a shows a schematic view of a delivery device that includes adose chamber having an opening that is sealed by a moisture barrier, andan opening mechanism positioned outside of the chamber that pivots toopen the dose chamber, according to one embodiment.

FIG. 1 b shows the embodiment of FIG. 1 a, with the opening mechanism inan open position.

FIG. 2 a shows a schematic view of a delivery device that includes adose chamber having an opening that is sealed by a moisture barrier, andan opening mechanism with a cutter portion that is positioned on a dosechamber side of the moisture barrier.

FIG. 2 b shows the embodiment of FIG. 2 a, with the opening mechanism inan open position.

FIG. 2 c shows a variation of the embodiment of FIGS. 2 a and 2 b thatincludes a stationary structure to divert air to a dose chamber, and anopening mechanism with a cutter that fits within a cavity of thestationary structure when moved to the open position, according to oneembodiment.

FIG. 3 a shows a schematic view of a delivery device that includes afilling hole that provides access to the dose chamber and that is sealedby a barrier and an actuator that is accessible from a bottom surface ofthe device, according to one embodiment.

FIG. 3 b shows the embodiment of FIG. 3 a, in configured for delivery adose.

FIG. 4 a shows a schematic view of a delivery device that includes adose chamber formed of barrier material, and a cutter that is positionedinside of the dose chamber.

FIG. 4 b shows the embodiment of FIG. 4 a, with the opening mechanism inan open position.

FIG. 5 a shows a schematic view of a delivery device that includes adose chamber formed of barrier material and having an opening mechanismpositioned inside of the chamber that may be actuated directly fromoutside of the chamber.

FIG. 5 b shows the embodiment of FIG. 5 a, with the opening mechanism inan open position.

FIG. 6 a shows a schematic view of a delivery device that includes anopening mechanism that translates from a first position to a secondposition to ready a dose for delivery.

FIG. 6 b shows the embodiment of FIG. 6 a, with the opening mechanism inthe second position.

FIG. 7 a shows a side view of air flow through the air pathway and dosechamber of a delivery device during delivery of a powdered medicament,according to one embodiment.

FIGS. 7 b and 7 c show delivery devices having openings between a dosechamber and air pathway configured to alter flow properties, accordingto some embodiments.

FIG. 8 shows a perspective cutaway view of air flow through the airpathway and dose chamber of a delivery device, according to oneembodiment.

FIG. 9 shows a delivery device that includes a restriction in the airpathway, upstream of an opening to a dose chamber, according to oneembodiment.

FIG. 10 shows a delivery device that includes a first set of vents thatlead into the air pathway, upstream of an opening to a dose chamber, anda second set of vents that lead into the air pathway, downstream of theopening, according to one embodiment.

FIG. 11 shows a delivery device that include a bypass between a dosechamber and downstream portion of an air pathway, according to oneembodiment.

FIG. 12 shows a cover portion of an opening mechanism that issubstantially triangle shaped, according to one embodiment.

FIG. 13 shows a cover portion of an opening mechanism that includes apair of substantially triangle shaped portions, according to oneembodiment.

FIGS. 14 a-14 c show a delivery device that includes separate inlet andoutlet regions of an opening between an air pathway and a dose chamber,an air inlet channel and an air outlet channel that lead to an openingof a dose chamber, and a primary air path that has a U-shaped structure,according to one embodiment.

FIG. 15 shows a schematic view of a delivery device that includesdiverters facing both upstream and downstream in an air pathway,according to one embodiment.

FIGS. 16 a-16 c show one illustrative embodiment of a multi-dose device.

FIGS. 17 a-17 c show the position of a dose within a delivery device asthe device is opened, and moved to as subject's mouth for delivery.

FIGS. 18 a-18 b show one embodiment of a delivery device that includes adose chamber that moves relative to a cutter and air pathway to ready adose to be dispensed.

FIGS. 19 a-19 c show another embodiment of a delivery device thatincludes a dose chamber that moves relative to an air pathway to ready adose to be dispensed.

FIGS. 20 a and 20 b show cross-sectional views of a dose chamber, incombination with features located downstream of the dose chamber forfurther dispersing dose.

FIGS. 21 a and 21 b show a cross-section view of yet another embodimentof a delivery device.

DETAILED DESCRIPTION

Delivery devices described herein include one or more dose chambers forstoring and delivering a dose of a substance, such as a powderedmedicament, to a subject. The dose chamber may be placed in fluidcommunication with an air pathway to ready the medicament for deliveryto the subject. Air is drawn or pushed through the air pathway and atleast a portion of the air enters the dose chamber to entrain medicamentin a metered manner. Air then reenters the air pathway from the dosechamber, laden with powder from the dose chamber, and moves towards anoutlet of the delivery device to a subject.

According to one aspect, a delivery device includes an air pathway and adose chamber having a cover that, in a first position, holds a dose inthe dose chamber. The cover, when actuated, pivots to a second positionwhere the cover may direct air into the dose chamber to entrain dosebefore returning to the air pathway to deliver the dose to a subject.

According to another aspect, a delivery device has a dose chamber withan opening that is sealed by a barrier to prevent the ingress ofmoisture and contaminants to the chamber and/or the egress of dose fromthe chamber. A cutter or cover of the device may move, such as bypivoting, from a first position to a second position to break themoisture barrier and open fluid communication to an air pathway. When inthe second position, the cutter or cover may promote recirculation ofair through the dose chamber by being positioned in front of the path ofair that leads back to the air pathway from the dose chamber.

According to another aspect, a cutter may be positioned on a dosechamber side of the barrier of a delivery device. The cutter may move,such as by pivoting or translating, when actuated, to break the moisturebarrier and open fluid communication between the dose chamber and theprimary air pathway.

Turn now to the figures, and initially FIGS. 1 a and 1 b, which show across-sectional view of a delivery device, according to one illustrativeembodiment. The device includes an air pathway 22 and a sealed dosechamber 34 that contains a dose 36 of powdered medicament, or othersubstance to be delivered through an opening to the air pathway 22 andeventually to a subject. The chamber, as illustrated in the embodimentof FIGS. 1 a and 1 b, is generally cylindrical in shape, although othershapes are also possible. The chamber is formed of an upper housing 40and a lower housing 42 that may be formed of injection molded plastic,among other materials. A barrier 28 is mounted about the opening 36 toprovide a selectively openable, air impermeable seal that prevents inthe ingress of moisture or contaminants to the dose chamber while alsoretaining a dose in the chamber until ready to be dispensed. An openingmechanism 30 of the device includes a cover portion 46 positioned overthe opening to the dose chamber and a cutter portion 24 to break thebarrier when a dose is readied for dispensing. The opening mechanism ismounted to the barrier and is movable from a first position as shown inFIG. 1 a, where a dose is sealed within the dose chamber, to a secondposition as shown in FIG. 1 b for dispensing a dose from the chamber.When in the second position, the cover and cutter portions of theopening mechanism, as shown in FIG. 1 b, move into the air pathway todirect a portion of air to the dose chamber, as air moves through thedelivery device.

It is to be appreciated that the general construction of the inhalationdevice shown in FIGS. 1 a and 1 b is but one embodiment and that othergeneral constructions are also contemplated, some of which are shown inand described with respect to FIGS. 3 a, 3 b, 4 a, 4 b, 5 a, 5 b, 6 a,and 6 b. FIGS. 2 a and 2 b show another illustrative embodiment of adelivery device having an opening mechanism that is positioned on a dosechamber side of a barrier. As shown in FIG. 2 b, the opening mechanismmay be rotated about a pivot point 32 when an actuation region of theopening mechanism is moved to cause a cutting portion of the mechanismbreak the moisture barrier and to move the cover portion from theopening to provide fluid communication between the air pathway and thedose chamber. The cover portion of the cutter also moves further intothe air pathway to direct air to the dose chamber, as in the embodimentof FIGS. 1 a and 1 b.

The embodiment of FIG. 2 c includes some features similar to those ofFIGS. 2 a and 2 b, but also has a stationary structure 48 that divertsair from the air pathway 22 to the dose chamber. The cutter/coverportion of the opening mechanism in the embodiment of FIG. 2 c may bereceived in a cavity 50 in the stationary structure. In this embodiment,the cover and/or cutter portion of the opening mechanism may beconsidered to span across or cover a cavity that receives thecover/cutter. Such a configuration may allow the design of thecover/cutter and the structure that diverts air to the dose chamber tobe independently optimized, although the cover/cutter may still includefeatures that promote delivery of air to or recirculation of air throughthe dose chamber. For example, the structure that diverts air to thedose chamber may be substantially larger than the opening to the dosechamber, according to some embodiments. Additionally or alternatively,the diverting structure may be more easily shaped to prevent dose fromtraveling downstream in the air pathway 22, until drawn through thedevice by a subject, as is discussed herein with respect to the U-shapedair pathway in the embodiment of FIGS. 14 a-14 c. Various embodimentsmay, additionally or alternatively, include diverter like-structures,U-shaped air pathways, or other features that prevent dose fromtraveling in other directions, such as an upstream direction, or toprevent dose from exiting a dose chamber inadvertently. Conversely, acutter may be optimized to cut foil or conform to the opening betweenthe air pathway 22 and dose chamber, rather than for diverting air to adose chamber.

The illustrative embodiment of FIGS. 3 a and 3 b shares many feature into the embodiment of FIGS. 2 a and 2 b, but also includes a hole thatextends to the dose chamber from outside of the delivery device, andthat may be used to fill the dose chamber with a dose of powderedmedicament or other substance. The opening mechanism, as shown, isintegral with an actuator 52 that may be depressed to move themechanism, including the cutter portion and cover portion, from thefirst position shown in FIG. 3 a to the second position shown in FIG. 3b. Barrier layers are positioned both over the opening between the dosechamber and the air pathway, and over the filling hole and access holeto the actuator to prevent the ingress of moisture/contaminants to thedose chamber, and the egress of dose from the device. As shown, theactuating mechanism may be accessed from a side of the dose chamber thatis opposite to the air pathway, a configuration that may have ergonomicadvantages.

FIGS. 4 a and 4 b show an embodiment of a delivery device that has alower housing that is formed of a deformable barrier material, such as afoil rather than a rigid plastic structure, to define a portion of thedose chamber. Forming the lower housing and/or other components of adelivery device out of foil or other barrier material may facilitateefficient manufacturing and/or reduce the cost to produce a deliverydevice. Additionally or alternatively, barrier materials may provide adose chamber that is more resistant to moisture than dose chambers madeof other materials. As shown, the lower housing includes a pivot pointabout which an opening mechanism, captured within the dose chamber, mayrotate. The delivery device of FIGS. 4 a and 4 b may include an actuatorthat may be accessed from outside of the device to ready a dose fordelivery, and/or other features of various embodiments that arediscussed herein but that are not shown in FIGS. 4 a and 4 b.

The embodiment of FIGS. 4 a and 4 b includes a cavity between thepositive stop 44 and actuating portion 26 of the opening mechanism, whenthe dose chamber is closed. This cavity is occupied by the actuationportion when the opening mechanism is moved to cut the barrier and openthe dose chamber. The opening mechanism may be fit closely to the lowerhousing and the barrier at positions near the pivot to prevent portionsof the dose from migrating to the cavity, which might otherwise preventthose portions of the dose from being delivered from the deliverydevice, or prevent the opening mechanism from being completely opened.

The embodiment illustrated in FIGS. 5 a and 5 b also has a dose chamberthat is formed by a foil-on-foil structure. An opening mechanism on thedose chamber side of a barrier includes an actuating portion that may beactuated directly from outside of the chamber to move the mechanism fromthe first position of FIG. 5 a to the second position of FIG. 5 b toready a dose for delivery. This may be accomplished by moving theactuating portion that extends from the dose chamber downward. As shown,a tab 58 of barrier or other material may be included on the mechanismto facilitate actuation.

In each of the embodiments of FIGS. 1 a-5 b, an opening mechanism maymove through a pivoting motion when opening a dose chamber and readyinga dose for delivery. By way of example, in the embodiment of FIGS. 1 aand 1 b the opening mechanism is adhered to an air pathway side of thebarrier in a manner that creates a pivot point at the downstream edge ofthe opening. The opening mechanism also includes an actuation region orportion, shown extending into the air pathway 22 in FIG. 1 a, that maybe depressed to cause the mechanism to rotate about the pivot point whenmoving from the first position to the second position. The dose chamberside of the cover portion generally follows a rotating motion whenmoving from a position over the opening to a position extendingpartially into the air pathway 22. In embodiments that have a dosechamber formed of a barrier material, such as deformable foil that formsa lower housing in the embodiments of FIGS. 4 a, 4 b, 5 a, and 5 b, itis to be understood that the pivoting motion may accompany deformationof the lower housing and/or the upper housing, such that the pivot pointmay not be held in a constant position as opening mechanism is actuated.In some embodiments, the housing may include features to promotedeformation in a particular manner, such as by including a crease linealong a desired bend point. It is to be appreciated that otherembodiments may include opening mechanism that ready a dose for deliverythrough other motions, such as by translation or through combinations ofrotation and translation, as is discussed in greater detail herein, andthat the embodiment of FIGS. 1 a and 1 b is not to be consideredlimiting in this respect.

FIGS. 6 a and 6 b show one embodiment of a delivery device in each of afirst and second position, respectively, and that has an openingmechanism that translates, rather than pivots. The dose chamber isformed between an upper and lower housing, and includes a fill opening54, as in the embodiment of FIGS. 3 a and 3 b. A foil-on-foil coversurrounds the entire dose chamber and opening mechanism to provide alight, moisture, and/or contaminant barrier for any dose containedtherein. To ready a dose for delivery, a user moves the openingmechanism from the position shown in FIG. 6 a to the position shown in 6b, either by moving an actuator (not shown) that acts on the mechanism,or by pressing on the mechanism directly. This causes the mechanism totranslate, pressing a cutter portion of the mechanism into and shearingthe barrier while moving a cover portion away from the opening. Thecutter portion/cover portion then moves into the air pathway to aposition where air flow will be diverted to the dose chamber, as isdescribed in greater detail herein with respect to various embodiments.In other embodiments, opening mechanisms may translate in otherdirections, relative to a dose chamber to open fluid communication to anair pathway 22, or may translate in combination with rotating, asaspects of the invention are not limited in this respect.

Once a dose is readied for delivery by actuating an opening mechanism,air is moved through the pathway either by being drawn or pushed throughthe delivery device, actively or passively, to entrain the dose from thechamber and deliver the dose to a subject. As shown in FIG. 7 a, whichis a schematic side view of air flow through the embodiment of FIGS. 1 aand 1 b, air moves from an upstream portion of an air pathway toward adownstream portion 64. The cover portion, when in an open position, ispositioned at least partially in the air pathway to direct a portion ofthe air moving through the pathway to the dose chamber. In theillustrated embodiment, air that enters the dose chamber progressesalong the dose chamber side of the cover portion and then follows thesubstantially curved interior wall of the dose chamber until the airflow is directed back towards the opening and/or the dose chamber sideof the cover. A portion of the air that is directed back toward thecover of the dose chamber may be recirculated back through the dosechamber by air that is entering the dose chamber, or by the coveritself. Another portion of the air, however, exits the dose chamber tore-enter the air pathway and move downstream to deliver dose, entrainedfrom the chamber, to the downstream portion of the air pathway andeventually to a subject. It is to be appreciated that although airand/or dose recirculation may occur in the embodiment of FIGS. 1 a and 1b, such recirculation may not occur in other embodiments. By way ofexample, according to some embodiments, a chamber may be opened to allowair to enter and then directly pass through a chamber, as dose isentrained.

Recirculation of air through the chamber, as described above, maypromote an even metering of dose from the dose chamber by preventing anentire dose, or a substantial portion of a dose, from exiting thechamber as a bolus or clump of powder. Additionally or alternatively,recirculation may promote the retention and break up of any largeragglomerated particles prior to being delivered from the dose chamber.This may occur as entrained particles tumble about the chamber and arebroken down into smaller particles for improved delivery. Additionally,larger particles entrained within the flow may have too much momentum toturn back toward the opening, as the flow of air turns toward the airpathway to exit the chamber. These larger particles may continue on apath toward the dose chamber side of the cutter or cover and becomeentrained in the flow of air that is entering the chamber. In thisrespect, the larger particles may be recirculated back through thechamber, at least longer so than smaller particles, to bede-agglomerated into smaller particles prior to delivery. Particles overa threshold size may be retained within the dose chamber indefinitely,according to some embodiments.

The shape of size or the opening between a dose chamber and air pathwaymay be altered to, in turn, alter recirculation characteristics or otherflow characteristics of a delivery device. By way of example, FIG. 7 bshows another embodiment that has an opening with an upstream edge thatis positioned further downstream than in the embodiment of FIG. 7 a.This reduces the size of the opening, which causes flow to recirculatelonger within the dose chamber. The wall of the dose chamber in FIG. 7 bis also angled to direct flow more toward an inside portion of theopening, and less toward the air pathway, at least with respect to theembodiment of FIG. 7 a, which also causes dose to recirculate within thechamber to a greater degree than in the embodiment of FIG. 7 a. Theembodiment FIG. 7 c includes an opening that has overlapped upstream anddownstream edges, which further increases the amount of recirculationthat occurs within a dose chamber. It is to be appreciated that otherfactors may be altered as well to modify flow and recirculationcharacteristics through a dose chamber. For instance, in someembodiments, the opening between the dose chamber and air pathway mayhave a smaller width (that is, the direction into/out of the page inFIGS. 7 a-7 c) than the dose chamber and/or the air pathway. Decreasingthe width of the opening, all else constant, will generally increase theamount of dose recirculation that occurs within a dose chamber.

The curved shaped of the dose chamber, according to some embodiments,may also help promote metered delivery of dose from a delivery device.As shown in FIG. 7 a, dose may also be pushed outwardly against theinterior wall of the dose chamber as air circulates about the chamber.Air that then flows across the surface of the medicament may entrainparticles of the medicament, in a metered manner, as the flow progressesabout the dose chamber. As shown, the interior surface of the chambersubstantially lacks sharp corners or pockets that might otherwise trapportions of a dose and prevent them from being delivered, or from beingdelivered in a metered manner. It is to be appreciated, however, thatother embodiments may include sharp corners or pockets that areintentionally placed to trap or retain portions of a dose, as retaininga portion of dose for a longer time period may be desirable in someembodiments.

The amount of recirculation that occurs in a dose chamber and/or therate at which dose is metered from a chamber by air flowing therethroughmay be controlled by the shape of a dose chamber and/or cover portion ofa delivery device. By way of example, decreasing the size of the openingbetween the air pathway and dose chamber may result in slower meteringof dose from the chamber, generally speaking. Additionally, orientingthe surfaces of the dose chamber to direct flow more toward the coverportion or other surfaces of the dose chamber, rather than out of thechamber through the opening, may result in a greater amount ofrecirculation and/or mixing within the chamber, and a slower rate ofdose metering from the chamber. In this respect, it is to be appreciatedthat although the dose chambers are illustrated as having primarilycylindrical cross-sectional shapes, that other configurations arepossible, including elliptical shapes, shapes having complex curvatures,or even more simplistic shapes, such as rectangular or partiallyrectangular, as aspects of the invention are not limited in thisrespect. Additionally or alternatively, openings between the air pathwayand dose chamber may be altered to, in turn, alter the rate at whichdose is metered from a dose chamber.

FIG. 8 shows the flow of air through an air pathway and dose chamberfrom a perspective top view, as may occur in the embodiment of FIGS.1-6. As represented by the arrows, air nearer to central portions of theair pathway typically travels at greater velocities than air nearer tolateral side walls of the air pathway, due to boundary effects at thewalls. The air that is moving faster toward the opening of the dosechamber may naturally provide a pathway for air to enter a dose chamber,as shown in FIG. 8. As is to be appreciated by those of skill in theart, the amount of air entering a dose chamber is equal to the amount ofair that exits the dose chamber, at least at steady state. Given this,portions of the air pathway in which air is moving downstream moreslowly, such as near lateral walls 72 of the air pathway, may provideless resistance against flow that is working back to the pathway fromthe dose chamber. FIG. 8 shows how air entering the chamber at a centralportion of the opening may travel in a corkscrew-like manner in eachlateral direction and about the substantially cylindrical surface of thedose chamber as the flow circulates about the chamber back towards theair pathway 22, near lateral portions of the opening. Interactions andor cross-flows between air that is entering and exiting the chamber atthe opening and interacting at other positions along the corkscrew-likepath may promote dispersion and/or de-agglomeration of powderedmedicament that is being delivered by the delivery device.

According to some embodiments, inhalation devices may include featuresto promote a particular shape of flow through a dose chamber, such asthe corkscrew-like path shown in FIG. 8, or other chaotic, eddyingpaths. By way of example, the embodiment of FIG. 9 incorporates bumps 74positioned on each lateral wall of the air pathway 22, upstream of theopening to the dose chamber. The bumps create a restriction at a centralportion of the air pathway that causes air flowing therethrough toincrease in velocity, while flow at areas near the lateral wallsdownstream of the restriction is slowed. Increasing and slowing flowthrough the air pathway in this manner may create a more pronouncedcorkscrew-like flow path through the chamber that may, in turn, increaseturbulence and mixing of dose in a delivery device. It is to beappreciated that the restriction shown in FIG. 9 is but oneconfiguration that may be used to promote a particular shape of flowthrough a dose chamber, and that others are also possible. Oneembodiment may be constructed like that shown in FIG. 9, but with only asingle bump forming a restriction. Here, flow velocity may be increasedalong the wall that lies opposite to the bump, while being sloweddownstream at the wall having the bump. Altering flow in this manner maypromote a flow shaped to have a single corkscrew-like path that leadsfrom one lateral side of a cylindrical chamber to the opposite lateralside. Other configurations are also possible, including arrangementsthat have a plurality of bumps or other features extending into the flowpathway to increase and/or decrease flow rates at a plurality of regionsand cause a greater amount of turbulence at the opening of a dosechamber or inside of a dose chamber.

According to some embodiments, vents 82 may be incorporated into aninhalation device to help form a particular shape of flow through thedevice. As shown in FIG. 10, vents may be positioned in the air pathway,upstream of the opening to the dose chamber. As air is moved through theair pathway from the upstream portion 66 towards the downstream portion,air is also drawn into the pathway through the vents. The vents may besized such that air passing through the vents moves at a slower ratethan air moving through the air pathway from an upstream portion. Flowin this manner can create an effect similar to that of the restrictiondiscussed above with respect to FIG. 9. Air traveling through centralportions of the pathway from the upstream portion moves at a greatervelocity than air traveling at lateral portions of the pathway, whichcan produce a corkscrew-like pattern, similar to that discussed abovewith respect to FIGS. 8 and 9. According to some embodiments, vents maybe angled to direct flow in a particular manner as the air enters thepathway.

Vents may be incorporated into a delivery device at other positions aswell. By way of example, the embodiment of FIG. 10 also includes ventsthat lead into the air pathway at a position downstream of the opening.Air that enters the pathway through these vents may cause furtherturbulence in the downstream pathway to provide additional mixing ofdose that is delivered from the chamber. Additionally or alternatively,the vents, when positioned circumferentially about the downstreamportion, may provide an annular shaped cushion of air about the flow ofair that contains an entrained dose. Having such an annular shapedcushion may prove beneficial in keeping the dose away from the walls ofthe air pathway and/or walls of a subject's throat during delivery tothe subject's lungs.

According to some embodiments, a bypass 84 may be incorporated into adelivery device between a dose chamber and a downstream portion of anair pathway 22, as shown in the embodiment of FIG. 11. The bypass mayallow some of the pressure in the dose chamber to be released to thedownstream portion of the air pathway, without necessarily allowing doseto be dispensed through the bypass. Reducing the air pressure level, inthis manner, may allow more air to enter the dose chamber to better mixand/or entrain medicament, and/or allow dose to be metered from thechamber at an increased rate. The cross-sectional size of the bypass,relative to the size of the opening to the dose chamber, may be adjustedto provide different degrees of bypass. Additionally or alternatively,the bypass may be shaped and/or may include features, such as a screen,to prevent dose from being delivered downstream, through the bypass. Itis to be appreciated, however, that in other embodiments, some dosedelivery through the bypass may be desirable, and that the bypass may beshaped and sized to promote the passage of dose therethrough. It is alsoto be appreciated that, according to some embodiments, two or morebypasses may be included in a delivery device, as aspects of theinvention are not limited to that shown in the figures.

The cover portion/cutter portion of the opening mechanism may extendinto the air pathway when the delivery device is readied for dosedelivery, and may be shaped to accomplish different effects. By way ofexample, according the embodiment shown in FIG. 12 the portion of thecover that extends to the pathway may be shaped substantially like atriangle, extending to a point 86 in the pathway and overlying asubstantially triangular opening to a dose chamber. In such anembodiment, the pointed end of the cover may divert faster flowing air76 from the central area of the air pathway, while also providinggreater room at lateral areas of the pathway and opening for air toescape from the dose chamber. Additionally or alternatively, the reducedarea of the triangle point may create greater pressure against abarrier, when the opening mechanism is actuated to open a dose chamber.It is also to be appreciated, however, that the cover may have adifferent shape than the opening, according to some embodiments. Forexample, in one embodiment a triangular shaped cover may overhang anopening having a square shape.

The cover portion embodiment of FIG. 13 includes a pair of points thatextend into the air pathway when the dose chamber is open. The pair ofpoints creates two primary areas in which air enters the dose chamberfrom the pathway. In this embodiment, air typically will exit thechamber near the lateral walls of the air pathway and often in the areabetween each of the points. A cover configured in this manner may createcorkscrew-like paths extending in each lateral direction away from areasunder each point as air flows through the dose chamber. This mayincrease the amount of turbulence in the device, enhancing dose mixingand de-agglomeration during delivery. As in the embodiment of FIG. 12,the points of the cover shown in FIG. 13 may also help to create highpressure areas when a barrier is opened. It is to be appreciated thatcutter portions may have different shapes, such as square, curved,circular, and more complex shapes, and that the shapes of FIGS. 12 and13, are merely examples associated with two embodiments.

In each of the embodiments of FIGS. 12 and 13, the cutter portion of theopening mechanism includes one or more points that may help concentrateforces to a high pressure point when opening a barrier that covers adose chamber opening. It is to be appreciated that other features mayalso be used to concentrate forces. By way of example, according to someembodiments, a cutter portion may include a raised point or edge toconcentrate forces against a barrier. The raised point or edge of thecutter may be formed by a slight bend in the opening mechanism,deformation of the opening mechanism, or by a localized portion of thecutter portion that is raised relative to adjacent portions. In otherembodiments, a sharp point or other type of energy directing featuresmay be incorporated into a side wall of an air pathway or directly intoa structure that overlies the barrier about the perimeter of an opening.The point may be contacted to break a barrier when the barrier is urgedupward by an opening mechanism. Other features may additionally oralternatively be incorporated into a delivery device, such as pre-scoredbarriers, and the like, as the examples shown in FIGS. 12 and 13 anddiscussed above are merely exemplary.

Various embodiments may also include features that allow a barrier to bereadily punctured. By way of example, the opening shown in FIG. 13includes a pointed structure that lies opposite to a pointed structureon the cover. These opposed, pointed structures interact to concentrateforces in a small area on the barrier that lies therebetween when theopening mechanism is actuated. This may result in a high pressure on thebarrier that promotes rupture and then tearing of a barrier. It is to beappreciated that the opposed points shown in FIG. 13 are but oneconfiguration of features that may help concentrate forces to promotebreakage of a barrier, and that others are also contemplated.

It may be desirable to prevent a barrier from being sheared in a waythat creates jagged and/or inconsistently sheared edges which mightotherwise extend into an air pathway and disrupt flow through a deliverydevice in an unpredictable manner or create catch points for dose thatis being delivered. According to some embodiments, the cutter portion ofthe opening mechanism and/or an edge of opening itself may includefeatures to promote a clean and consistent rupturing of the barrier whenthe dose chamber is opened. By way of example, in each of theembodiments of FIGS. 12 and 13, the upstream edge 68 of the cover andthe opening are formed to have a similar shape (except for the roundedareas near the points of the opening, discussed above with respect toFIG. 13) and to lie adjacent to one another when the dose chamber isclosed. In this manner, the line that lies between the upstream edge ofthe cover and the opening define a line along which the barrier will besheared, consistently, when opened. Other features may, additionally oralternatively, be incorporated into a device to promote consistentbarrier shearing. For example, barriers may be weakened along a desiredshear line, such as by scoring, to promote barrier rupture in aparticular manner.

According to some embodiments, a barrier may be sandwiched between apair of rigid structures near all or a portion of a perimeter about anopening, such as is shown in FIG. 2 c. Sandwiching the barrier, in thismanner, may promote clean and consistent rupture of the barrier whenopened, particularly where the forces associated with rupturing abarrier might be great enough to overcome the forces that keep thebarrier adhered to the perimeter of the opening, the coverportion/cutter portion, or other structure of a delivery device. Pointsor energy directors, like those discussed herein, may be incorporatedinto one or both structures that sandwich a barrier, according to someembodiments.

The cover portion of the opening mechanism may be shaped to completelyblock the opening to the dose chamber when in the closed position toprevent the escape of dose from the chamber and/or the ingress ofcontaminants, including moisture, as in the embodiments of FIGS. 1-6.According to some embodiments, however, the cover alone may seal a dosechamber, such that a barrier may be omitted from the inhalation devicealtogether. Additionally or alternatively, the cover may be larger thanthe opening, which according to some embodiments, may provide adiverting structure that extends further or that includes a largersurface area. It also is to be appreciated that in other embodiments,however, the covering portion may only occupy a portion of the openingwhen the dose chamber is closed, and that sealing may be accomplishedprimarily or solely with a barrier.

The barrier that is incorporated into some embodiments may be formed ofvarious materials. According to some embodiments, the barrier includesan aluminum foil that is substantially impervious to light and moisture,although in other embodiments, barriers may be permeable to some degreeof moisture and light. The barrier may be readily adhered to otherbarriers, such as for foil-on-foil embodiments described herein, or toother structures of a delivery device, that are often formed of plastic.Adhesives, heat weld, friction welds, and other fastening techniques maybe used to affix barriers and to provide a seal between the barrier andmating structure.

According to some embodiments, the cover may be constructed to moveconsistently to the same open position, which may help promoteconsistent delivery of air to the dose chamber and of dose from the dosechamber. A positive stop may be incorporated in the device that, whenreached, prevents an opening mechanism and cover portion from openingfurther. By way of example, the cover in the embodiment of FIGS. 1 a and1 b is prevented from opening further when the opening mechanism abutsthe air pathway 22, as shown in FIG. 1 b. The embodiment shown in FIG. 2a also includes a positive stop in a cavity at the bottom of the airpathway that receives the actuating portion of the opening mechanism andthat prevents further movement of the cover when abutted by the openingmechanism. Additionally or alternatively, the opening mechanism may beshaped to have a slight interference fit with the air pathway 22, orother portions of the delivery device, which may help hold thecover/opening mechanism in the open position. According to someembodiments, the edges of the cutting or covering portions may be spacedslightly from the walls of the air pathway to allow edges of a shearedbarrier to be wiped by the passing of the opening mechanism, and movedout of the airflow pathway.

Delivery devices may include features to retain the position of a pivotpoint of an opening mechanism during and/or after the opening of a dosechamber. In the embodiment of FIGS. 1 a and 1 b, the opening mechanismis held relative to the air pathway by the barrier. Here, the barrieracts as a living hinge to hold the pivot point steady when and after thecover is opened. Similarly, in the embodiment of FIGS. 2 a and 2 b, theopening mechanism is held to the delivery device by a pin joint thatacts as a pivot. In other embodiments like those of FIGS. 4 a, 4 b, 5 a,and 5 b, portions of the barrier that are attached to both the openingmechanism and the air pathway remain intact as the cover moves to theopen position. These portions help keep the pivot point between thecover and the air pathway in a common position both during and after thedose chamber is opened.

Although not shown in all of the drawings, each of the embodiments ofFIGS. 1-6, may include a plunger or other type actuator that may beactuated by a user to move an opening mechanism from a first position,where a dose chamber is closed, to a second position, where the dosechamber is opened to ready a dose for delivery. By way of example, aplunger may extend downwardly and through the air pathway to press onthe actuation portion of the opening mechanism in either of theembodiments shown in FIGS. 1 a, 1 b, 2 a, and 2 b. Various mechanismsmay be used to move the plunger downward and/or to return the plungerfrom the air pathway 22, once a dose has been readied for delivery. Onenon-limiting example of such a mechanism includes a plunger that mayextend, when actuated, from an upper surface of the delivery deviceshown in either of the embodiments of FIGS. 1 a, 1 b, 2 a, and 2 b,directly above an actuating portion of the opening mechanism. A springor other biasing element may be incorporated into the inhalation deviceto move the plunger away from the opening mechanism, after actuation.

It is to be appreciated that the embodiments of FIGS. 1-6 and thevariations thereof, as discussed above, are non-limiting examples of thetypes of delivery devices that may incorporate the various inventionsdescribed herein, and the inventions may additionally or alternativelybe incorporated into different embodiments. FIGS. 14 a-14 c show yetanother embodiment of a delivery device that incorporates variousaspects of the inventions discussed herein with respect to otherembodiments. As shown, the device includes a lower housing that mateswith an upper housing to define a dose chamber therebetween. The devicehas a primary air pathway 118 that includes a U-shaped downstreamportion. A chamber inlet pathway, separate from the primary air pathway22, provides an inlet to the dose chamber. A chamber outlet pathwayconnects the dose chamber to the primary air pathway 22. A barrier, suchas a foil, is sandwiched between the upper and lower housings to seal anopening of the dose chamber and to retain and protect a dose ofmedicament in the chamber until ready to be dispensed. An openingmechanism is also sandwiched between the upper and lower housings. As inother embodiments discussed herein, the opening mechanism includes acutter portion positioned inside of the chamber and that may move orpivot from a first position, for storing a dose, to a second position tobreak the barrier at the opening of the dose chamber, placing the dosechamber in fluid communication with the primary air pathway through eachof the inlet and outlet pathways.

As may be seen in FIG. 14 b, the opening mechanism may be received in acavity in the air inlet 90 and outlet 92 channels to direct flow to thedose chamber, rather than extending into a primary air pathway, as inother embodiments described herein. In this respect, the cover and/orcutter portion of the opening mechanism may fit within a largerstructure that diverts air toward a dose chamber, and may be consideredto span across or cover a cavity that receives the cover/cutter.

As shown in FIGS. 14 b and 14 c, the inlet and outlet pathways are influid communication with the dose chamber at laterally separate portionsof the chamber. That is, discrete inlets and outlets to the chamber aredefined by structures of the device, unlike in some other embodiments.These discrete inlets and outlets may be positioned to cause flow tocorkscrew 70 through the dose chamber from one lateral end to the otherlateral end as the flow moves from the primary air pathway, through theinlet pathway, dose chamber, and then outlet pathway. Alternatively, thediscrete inlet(s) and outlet(s) may be positioned to allow air to passdirectly through the chamber, entraining dose without substantialrecirculation or corkscrewing, as aspects of the invention are notlimited in this respect. It is also to be appreciated that the deviceshown in FIGS. 14 a-14 c, or variants thereof, may be used without aprimary air pathway. That is, air may flow directly to the air chamberthrough an air inlet pathway, and then directly to a subject, through anoutlet pathway, such that substantially all of the air that enters thedevice, passes through the dose chamber.

FIG. 15 shows yet another embodiment of a delivery device that may beused to meter the delivery of a dose to a subject. As shown, the deviceincludes covering portions or diverters 94 that face both in theupstream direction and the downstream direction of the primary airpathway. Each diverter is positioned at a laterally separate portion ofthe opening to the dose chamber to define an entrance and exit from thedose chamber, as in the embodiment of FIGS. 14 a-14 c. Air flow mayenter the dose chamber in a manner similar to that discussed herein withrespect to the embodiments of FIGS. 1-6. However, the diverter thatfaces downstream substantially reduces resistance to outlet flow fromthe dose chamber. This may result in substantially less circulation offlow in the dose chamber and a more rapid delivery of a dose therefrom,which may be desirable for some applications. It is to be appreciatedthat although the diverters shown in FIG. 15 are constructed similarly(except for facing different directions) that other embodiments may havediverters constructed differently, such as by having different widths,heights, or general shapes. It is also to be appreciated that each ofthe diverters shown in the embodiment of FIG. 15 may act as openingmechanisms that, when operated, rupture a barrier to or from the dosechamber to provide access thereto. Other embodiments may, additionallyor alternatively, include multiple cutters/covers, as aspects of theinvention are not limited in this respect.

It is to be appreciated that although various embodiments of thedelivery devices are discussed and illustrated herein as single dosedevice, that a plurality of any of the delivery devices may beincorporated into a device that may deliver multiple doses.Incorporating multiple dose chambers into a common device may allow somefeatures of a delivery device to be shared among different dosechambers. By way of example, a multi-dose device may include a commonoutlet that is used to deliver, sequentially, doses from each of thedose chambers to a subject, when needed. Other features may be sharedamong the different dose chambers of a common, multi-dose device, suchas a single actuator/plunger that is moved sequentially intoregistration with each dose chamber to move an opening mechanism betweena first and second position to ready a dose for delivery.

FIGS. 16 a-16 c illustrate one embodiment of a multi-dose device thatincorporates the delivery device described herein with respect to FIGS.14 a-14 c. FIG. 16 a shows an external view of the device, including anouter housing 98 that has an outlet 110 shaped to be received by themouth of a subject and that may be placed, sequentially, in fluidcommunication with the air pathways of each delivery device when a doseis readied for delivery. The device also includes a button 100 that maybe actuated to move delivery devices inside of the device sequentiallyinto registration with the outlet to ready a dose for delivery and/or tomove an actuator to open a dose chamber, as discussed herein. Thehousing also includes a window through which a dose counter 102 may beviewed so that a user may be aware of the number or doses that have beenexpended or the number of doses that remain. A cover 96, also shown inFIG. 16 a, may be positioned over the outlet, when the device is not inuse.

FIG. 16 b shows a disc 108 that incorporates a plurality of dose chamberand air path pairs, or “dispersion engines” as alternately referred toherein. The disc may be received into the housing of FIG. 16 a, as shownin the cross-sectional view of FIG. 16 c. Each of the dispersion enginesare oriented with the outlet of the air pathway facing toward the outeredge of the disc for alignment with the outlet of the multi-dose device.Each dispersion engine also includes an interface that mates with thebutton or other actuator of the multi-dose device to facilitate movementof an opening mechanism that may open a dose chamber to ready a dose fordelivery. The disc also includes indexing features 106 that may beengaged when the button is actuated to sequentially move differentdispersion engines into alignment with the outlet.

FIGS. 17 a-17 c show, schematically, the dispersion engine embodiment ofFIGS. 14 a-14 c, incorporated into the multi-dose device of FIGS. 16a-16 c progressively as the dose chamber is opened and moved to asubject's mouth to be dispensed. The multi-dose device of FIGS. 16 a-16c is designed such that a subject naturally may hold the device in theattitude shown in FIG. 17 a, when the subject is readying a dose to bedispensed by pressing the button on the lower side of the device. Asshown in FIG. 17 a, the cover portion and outlet channel of the deviceare shaped to retain dose within the chamber when held at this attitude,even after the dose chamber has been opened. This may prove beneficialfor any of several reasons. First, retaining dose within the dosechamber prior to intentionally being dispersed may prevent portions orall of a dose from being lost. Additionally or alternatively, havingmost or all of the dose consistently in the chamber at the beginning ofthe delivery process may result in more consistent drug deliverycharacteristics. FIG. 17 b shows the position of the powder within thedose chamber as the subject moves the multi-dose device toward theirmouth to dispense the dose, and FIG. 17 c shows the device in theattitude that subject would normally hold the device when dispensing adose. As can be seen, the configuration of the dose chamber retains thedose as the user moves the device toward their mouth.

The U-shaped downstream portion of the air pathway is positioned tocatch powder, in the bight 88 of the U that may escape from the dosechamber when opened, particularly in the attitude shown in FIG. 17 a.This may prevent any dose that escapes the chamber from being lost priorto the dose being delivered from the device to a subject. The U-shapedportion of the pathway may additionally create turbulence that serves tofurther disperse dose after exiting the chamber when being dispensed toa user. It is to be appreciated that although the U-Shaped portion isshown only in connection with the embodiments of FIGS. 14 a-14 c and 17a-17 c, that similar structures and variations thereof may beincorporated into any other embodiments. It is also to be appreciatedthat, according to some embodiments, a U-shaped structure or otherstructure that may prevent the escape of dose may be positioned upstreamof the dose chamber.

FIGS. 18 a and 18 b show yet another embodiment of a delivery devicethat includes a dose chamber and air pathway. This illustrativeembodiment includes an air pathway that is integral with a cutter andstructure that diverts air from the air pathway and along the cutter toa dose chamber when present. A dose chamber that is sealed on one sideby a barrier may be moved into contact with the cutter (alternatively,the cutter and air pathway may be moved toward the dose chamber) tobreak the barrier, placing the dose chamber and air pathway in fluidcommunication, as shown in FIG. 18 b. Air may then be drawn through thedevice to deliver a dose to a subject.

Yet another embodiment of a delivery device that includes a dose chamberthat may be moved relative to an air pathway is shown in FIGS. 19 a-19c. The device includes an air pathway structure that may mate with acylindrical housing which encloses a dose chamber. The dose chamberinside of the cylindrical structure includes a diverter that directs airfrom the air pathway and into the dose chamber through an opening, whenin a position to deliver dose to a subject. The opening of the dosechamber may be sealed by a barrier that is punctured by a cutter in theair pathway structure or on the dose chamber when the dose chamberhousing is moved into the open position by translating the dose chamberhousing sideways (into the page, as shown in FIG. 19 c) to place thedose chamber and air pathway in fluid communication with one another.

In some embodiments, the devices, systems and methods may be free ofsecondary packaging to facilitate rapid and easy delivery of the drugwhen the drug needs to be delivered as fast as possible under astressful circumstance, such as in a rescue situation.

Embodiments described herein may be configured for passive or activeapplications, or a combination of passive and active fluidadministration. For example, each of the embodiments described hereinmay include use of a compressed fluid to assist in dispersing the drug.

The devices and systems described herein may be integrated into a widevariety of delivery configurations including, for example, a single-doseand multi-dose applications, in either active, passive, oractive/passive applications. In addition, the devices, systems andmethods may be applied to combination dose configurations and therapies.

The various embodiments described herein may be used in combination withother features that promote dispersion and/or entrainment of dose in adelivery device. By way of example, FIGS. 20 a and 20 b showcross-sectional views of a delivery device that includes a dose chamber,and a dispersion device, positioned downstream from the dose chamber. Inuse, air is drawn into the air inlet, toward a stationary diverter. Thediverter directs a portion of the air toward the dose chamber, and theremaining air moves directly toward the downstream dispersion device.The dose chamber, as shown in FIG. 20 b, includes a blister pack with acutter positioned internally therein, as described in U.S. patentapplication Ser. No. 61/285,161, filed Dec. 9, 2009, which is herebyincorporated by reference in its entirety. After dose has beenentrained, the dose laden air moves to the downstream dispersion devicewhere further mixing and dispersion occur. Additionally, a portion ofthe air moves directly to the dispersion chamber from the dose chamberthrough a bypass. The downstream dispersion device shown in FIG. 20 a,is configured to have a torus shape. Air enters the dispersion devicefrom a central location, and swirls circumferentially about the torusshaped chamber, allowing air and dispersed particles to exit the chamberthrough a central portion, similar to dispersion devices discussed withrespect to some embodiments of U.S. patent application Ser. No.61/285,161. It is to be appreciated that the embodiment of FIGS. 20 aand 20 b show but one type of downstream dispersion device, and thatothers are also possible and contemplated. By way of example, accordingto other embodiments, dispersion devices may include swirl chambers,mesh screens, rotors, classifiers, piezoelectric dispersion devices, andthe like.

FIGS. 21 a and 21 b show yet another embodiment that includes a dosechamber located in a lower housing that slides between a first position,where the dose chamber is closed, and a second position where the dosechamber is open to a primary air pathway. The primary air pathway islocated in an upper housing, and includes a stationary diverter thatdirects air flow to the dose chamber. The dose chamber of the lowerhousing may be sealed to the upper chamber by virtue of a direct sealingbetween the upper and lower housings (e.g. plastic-on-plastic),according to some embodiments. According to other embodiments, a barriermaterial may seal the dose chamber, and may be pealed away from the dosechamber during movement of the lower housing.

The devices, systems and methods described herein may be used to delivermaterials, other than a drug/medicament, to the body. The materials maybe delivered through the mouth or nose and into the oral cavity, nasalcavity, and/or to the lungs. Materials that are intended to be deliveredinto the oral cavity include, for example, nutritional compositions(such as sugars, candy, food, vitamins, and quick energy supplements inliquid and/or powder (e.g., nanoparticles) form) and non-nutritionalcompositions (such as flavorants (e.g., esters)). Other materials thatmay be delivered into the oral cavity include those used for oralhygiene and dental treatment (e.g., breath fresheners, fluoridetreatments, teeth whiteners, antibacterial compositions, mouthwashes).Drugs and related compositions (such as anesthetics, therapeuticmarkers) may also be delivered into the oral cavity. Materials that themay be inhaled into the lungs include, for example, drugs (e.g., fortreating asthma, bronchitis, pneumonia) and therapeutic markers (such asdyes, scanning agents, radio labeling or tagging agents, UV labelingagents, contrasts agents in liquid and/or powder (e.g., nanoparticles)form). In this respect, it is to be appreciated that any of the abovematerials may be used in the devices, systems, and methods describedherein in place of drug(s)/medicaments. It is also to be appreciatedthat the terms “drug” and “medicament” are used interchangeable herein,and include any of the foregoing compositions and any others, whether inpowder, liquid or other form, that may be delivered to a human or animalfor therapeutic, diagnostic, or other effect. In certain aspects, thedelivery device is configured for use with other entranceways into ahuman or animal body, whether naturally formed or created otherwise, andwith aspects of the human or animal body other than the respiratorysystem. Although the embodiments described incorporate air as the fluidfor delivering the medicament, other fluids are contemplated as shouldbe apparent to one of skill in the art.

Having thus described several aspects of at least one embodiment of thisinvention, it is to be appreciated various alterations, modifications,and improvements will readily occur to those skilled in the art. Suchalterations, modifications, and improvements are intended to be part ofthis disclosure, and are intended to be within the spirit and scope ofthe invention. Accordingly, the foregoing description and drawings areby way of example only.

What is claimed is:
 1. A delivery device comprising: a primary airpathway having an upstream portion and a downstream portion; a dosechamber having an opening that, when opened, places the dose chamber andthe primary pathway in fluid communication at a position between theupstream portion and the downstream portion; and a cover that, in afirst position over the opening, closes fluid communication between thedose chamber and the primary air pathway and that moves to a secondposition to selectively open fluid communication between the dosechamber and the primary air pathway through the opening, the cover beingpositioned to divert air to the dose chamber from the upstream portionof the air pathway when in the second position.
 2. The delivery deviceof claim 1, further comprising: a moisture barrier that seals theopening.
 3. The delivery device of claim 2, further comprising: a cutterthat breaks the moisture barrier when the cover pivots to the secondposition to selectively open fluid communication between the dosechamber and the primary air pathway.
 4. The delivery device of claim 3,wherein the cutter is a part of the cover.
 5. The delivery device ofclaim 3, wherein the cutter is mounted to the moisture barrier.
 6. Thedelivery device of claim 5, wherein the cutter is mounted to a dosechamber side of the barrier.
 7. The delivery device of claim 5, whereinthe cutter is mounted to an air pathway side of the barrier.
 8. Thedelivery device of claim 3, wherein the cutter includes a feature toincrease pressure at an area of the moisture barrier when the cutterbreaks the moisture barrier.
 9. The delivery device of claim 1, whereinthe primary air pathway includes a restriction to increase the velocityof air flowing through central portions of the air pathway.
 10. Thedelivery device of claim 1, further comprising: a bypass that places thedose chamber in fluid communication with the downstream portion of theair pathway.
 11. The delivery device of claim 1, wherein cover ispositioned in the way of air that is returning to the air pathway fromthe dose chamber to promote recirculation of air in the dose chamber.12. The delivery device of claim 1, further comprising: an air outletthat leads from the opening of the dose chamber to the primary airpathway.
 13. The delivery device of claim 1, further comprising: a doseof medicament in the dose chamber.
 14. The delivery device of claim 1,wherein the cover moves from the first position to the second positionby pivoting.
 15. The delivery device of claim 1, further comprising adispersion device positioned downstream of the dose chamber.
 16. Amulti-dose device including a plurality of delivery devices according toclaim
 1. 17. The multi-dose device of claim 16, comprising a housingwith an outlet arranged to be placed, sequentially, in fluidcommunication with the primary air pathway of the plurality of deliverydevices.
 18. The multi-dose device of claim 17, further comprising anactuator to open the cover of a delivery device in fluid communicationwith the outlet.
 19. The delivery device of claim 1, wherein the coverincludes a diverter that faces in the upstream direction with the coverin the second position to direct a portion of air in the primary airpathway into the dose chamber.